Brilinta DaYu Study (DaYu)

A Multicenter, Single Arm, Open Label, Phase IV Study to Evaluate Safety and to Describe the Incidence of Major Cardiovascular Events of Ticagrelor in Chinese Patients With Acute Coronary Syndrome(ACS)

A multicenter, single arm, open label, Phase IV study to evaluate safety and to describe the incidence of major cardiovascular events of ticagrelor in Chinese patients with acute coronary syndrome

Study Overview

• Status: Completed
• Conditions: Acute Coronary Syndrome
• Intervention / Treatment: Drug: Ticagrelor

• Study Type: Interventional
• Enrollment (Actual): 2004
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100730
    • Research Site
  • Beijing, China, 100037
    • Research Site
  • Beijing, China, 100050
    • Research Site
  • Beijing, China, 100029
    • Research Site
  • Beijing, China, 100006
    • Research Site
  • Beijing, China, 100083
    • Research Site
  • Changchun, China, 130021
    • Research Site
  • Chengdu, China, 610041
    • Research Site
  • Chuangchun, China, 130041
    • Research Site
  • Fuzhou, China
    • Research Site
  • Fuzhou, China, 350001
    • Research Site
  • Guangzhou, China, 510080
    • Research Site
  • Guangzhou, China, 510220
    • Research Site
  • Jinan, China, 250012
    • Research Site
  • Jinan, China, 250021
    • Research Site
  • Jinan, China, 250033
    • Research Site
  • Jining, China, 272011
    • Research Site
  • Kunming, China, 650032
    • Research Site
  • Nanjing, China, 210009
    • Research Site
  • Nanjing, China, 210029
    • Research Site
  • Nanjing, China, 210012
    • Research Site
  • Shanghai, China, 200433
    • Research Site
  • Shanghai, China
    • Research Site
  • Shanghai, China, 200025
    • Research Site
  • Shenyang, China, 110016
    • Research Site
  • Shenyang, China, 110001
    • Research Site
  • Shenzhen, China, 518036
    • Research Site
  • Shenzhen, China, 518020
    • Research Site
  • Shenzhen, China, 518003
    • Research Site
  • Taiyuan, China, 030001
    • Research Site
  • Wuhan, China, CN-430022
    • Research Site
  • Wuxi, China, 214023
    • Research Site
  • Xiamen, China, 361004
    • Research Site
  • Xian, China, 710061
    • Research Site
  • Xian, China, 710032
    • Research Site
  • Xuzhou, China, 221006
    • Research Site
  • Zhengzhou, China, 450000
    • Research Site
  • Zhengzhou, China, 450012
    • Research Site
  • Zhongshan, China, 528403
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 130 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 1. Female or male aged at least 18 years 2.Index event of non-ST or ST segment elevation ACS 3.A patient who is considered as ethnic Chinese

Exclusion Criteria:

• 1. With coagulation disorder 2.Index event is an acute complication of PCI 3.Patient has planned for an urgent coronary artery bypass graft (CABG) within 7days from the enrolment 4.Oral anticoagulation therapy within 30 days prior to enrolment or cannot be stopped 5.Increased risk of bradycardic events 6. Concomitant oral or intravenous therapy (see examples below) with strong CYP3A inhibitors, CYP3A substrates with narrow therapeutic indices, or strong CYP3A inducers 7.Increased risk of bradycardic events (eg, no pacemaker and known sick sinus syndrome, second degree A-V block, third degree A-V block or previous documented syncope suspected to be due to bradycardia unless treated with a pacemaker). 8.Known clinically important thrombocytopenia 9.Known clinically important anaemia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ticargrelor; 90 mg/tablet, 1 tablet bid	Drug: Ticagrelor; 90mg/tablet, 1 tablet bid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bleeding Events	PLATO-defined fatal/life threatening, major, major+minor,major+minor+minimal	12 months
Serious Adverse Events Other Than Bleeding	SAEs except the blending events which have aleady been reported as SAEs.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major CV Events	Combination of CV death, MI, and stroke	12 months

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Runlin Gao, Doctor, Fu Wai Hospital, Beijing, China

Publications and helpful links

General Publications

• Gao R, Wu Y, Liu H, Su G, Yuan Z, Zhang A, Wang Y, Wang Z, Wang Y, Zhang H, Zheng Y, Liu L, Shen L, Leonsson-Zachrisson M, Han Y; DAYU study investigators. Safety and Incidence of Cardiovascular Events in Chinese Patients with Acute Coronary Syndrome Treated with Ticagrelor: the 12-Month, Phase IV, Multicenter, Single-Arm DAYU Study. Cardiovasc Drugs Ther. 2018 Feb;32(1):47-56. doi: 10.1007/s10557-018-6772-3.

Helpful Links

• D5130C00087 Clinical Study Protocol and amendment redacted

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2013
• Primary Completion (Actual): September 30, 2015
• Study Completion (Actual): September 30, 2015

Study Registration Dates

• First Submitted: June 4, 2013
• First Submitted That Met QC Criteria: June 5, 2013
• First Posted (Estimate): June 6, 2013

Study Record Updates

• Last Update Posted (Actual): April 3, 2018
• Last Update Submitted That Met QC Criteria: March 7, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease; Syndrome; Acute Coronary Syndrome; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Platelet Aggregation Inhibitors; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Ticagrelor
• Other Study ID Numbers: D5130C00087